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RecruitingInterventional

Reducing Exercise Intolerance Through Inspiratory Muscle Training in Obese Breast Cancer

NCT ID: NCT05193149Sponsor: Ohio State University Comprehensive Cancer CenterLast updated: 2026-01-07

Summary

The investigators propose a randomized controlled trial to determine the effectiveness of inspiratory muscle training in improving exercise tolerance among stage 0-III obese breast cancer survivors.

Detailed description

Randomized controlled trial (RCT) where obese participants (N=133) are randomized to 2 arms: \[i\] IMT 4 wks + Exercise 12 wks, \[ii\] SHAM 4 wks + Exercise 12 wks).

Arms & interventions

  • BehavioralInspiratory muscle training

    Training of respiratory muscles

  • BehavioralExercise training

    Supervised aerobic exercise intervention

Outcome measures

Primary

  • Change in exercise tolerance

    Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.

    Time frame: Baseline to 4 weeks

  • Change in exercise tolerance

    Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.

    Time frame: Baseline to 16 weeks

Secondary

  • Change in inspiratory muscle strength

    Time frame: Baseline to 4 weeks

  • Change in inspiratory muscle strength

    Time frame: Baseline to 16 weeks

  • Change in inspiratory muscle endurance

    Time frame: Baseline to 4 weeks

  • Change in inspiratory muscle endurance

    Time frame: Baseline to 16 weeks

  • Change in exercise capacity

    Time frame: Baseline to 4 weeks

  • Change in exercise capacity

    Time frame: Baseline to 16 weeks

  • Change in dyspnea

    Time frame: Baseline to 4 weeks

  • Change in dyspnea

    Time frame: Baseline to 16 weeks

  • Change in fatigue

    Time frame: Baseline to 4 weeks

  • Change in fatigue

    Time frame: Baseline to 16 weeks

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * completed active treatment for a Stage 0-III breast cancer diagnosis within 6 months to 5 years of enrollment. * obese as defined by a body mass index (BMI) of 30 to 50 kg/m2 * patients who are on adjuvant endocrine therapy will be allowed to participate. * sedentary (participating in less than 90 min of moderate intensity activity per week) and have at least one limitation in activity on the 10-question RAND-36 Physical Function Subscale to ensure some exercise intolerance Exclusion Criteria: * functional limitations that make independent exercise unsafe * metastatic breast cancer * ongoing or active infection with recent antibiotics or steroids * Bilateral Axillary lymph node dissection (ALND) of \>5 lymph nodes on each side, which could increase risk of lymphadenopathy with repeated blood pressure measurements during exercise or if patient has been advised by their clinician to avoid repeated BP measures on both arms. Bilateral Sentinel Lymph Node Biopsy (SLNB) will be allowed. * heart disease precluding exercise (congestive heart failure, unstable angina pectoris, cardiac arrhythmia) * psychiatric illness/social situations that would limit compliance with study requirements * orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise * unwilling or unable to follow protocol requirements * pregnant or nursing * any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study * presence of provokable ECG changes suggestive of heart disease, or dangerous arrhythmias or exercise induced hypertension, etc. during the cardiopulmonary exercise test * non-English speaking

Study locations (1)

The Ohio State University

Columbus, Ohio, 43210

Recruiting
Dharini M Bhammar, PhD · Contact
Dharini M Bhammar, PhD · Principal Investigator
Sagar Sardesai, MD · Principal Investigator
Inspiratory Muscle Training in Obese Breast Cancer Survivors | Cancerify